MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for STORZ ANESTHESIA ADAPTER FOR BRONCHOSCOPES manufactured by Karl Storz Endoscopy-america, Inc..
[183120484]
The patient was undergoing an elective cardiac cath and rigid bronchoscopy to assess for underlying conditions. During the bronchoscopy exam the equipment was unable to be attached to the ventilator system secondary to an incompatible adaptor. The patient became hypoxic, bradycardia and a code was called. The pals protocol was initiated, endotracheal tube was place, return of circulation occurred and the patient stabilized. By report, the general surgical provider attempted to utilize the connecting adaptor as indicated, but the size of the adaptor in the procedure kit did not allow for attachment of tubing to the ventilator. The adaptor should have a small end and a large end to secure into the system. This adaptor had two small ends allowing for leak of oxygen. The adaptor available is a re-usable adaptor. Storz anesthesia adapter for rigid bronchoscopes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9823794 |
| MDR Report Key | 9823794 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-12 |
| Report Date | 2020-02-28 |
| Date Reported to FDA | 2020-02-28 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ ANESTHESIA ADAPTER FOR BRONCHOSCOPES |
| Generic Name | BRONCHOSCOPE ACCESSORY |
| Product Code | EOQ |
| Date Received | 2020-03-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-12 |